Pilot Study of Fenofibrate for PSC

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University of Miami

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Primary Sclerosing Cholangitis

Treatments

Drug: fenofibrate

Study type

Interventional

Funder types

Other

Identifiers

NCT01142323
20100533

Details and patient eligibility

About

The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).

Enrollment

8 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male and female patients of 18 to 75 years old
  • Confirmed diagnosis of PSC including typical findings of stricturing and dilatations of the intra and/or extrahepatic biliary ducts in radiographic exam, (endoscopic retrograde cholangiopancreatography -ERCP, percutaneous cholangiogram - PTC or magnetic resonance cholangiopancreatography- MRCP)
  • Serum alkaline phosphatase levels elevated to at least 1.5 times the upper limit of normal.

Exclusion criteria

  • Hypersensitivity to fenofibrate
  • Prisoners and institutionalized subjects
  • Pregnant or nursing women
  • Anticipated need for liver transplantation in one year
  • Recipients of liver transplantation
  • Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
  • Co-existing liver diseases including auto-immune and viral hepatitis
  • Acute or chronic renal failure, defined as glomerular filtration rate (GFR)< 60 ml/min, GFR calculated using the Modification of Diet in Renal Disease (MDRF) GFR calculator
  • Known cholecystitis
  • Current use of statins
  • Current use of coumadin anticoagulant therapy
  • Previous history of, or known high risk for, venous thromboembolism,

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Fenofibrate
Experimental group
Description:
fenofibrate 160 mg po daily
Treatment:
Drug: fenofibrate

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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